FEATURE Pharmaceuticals
Cutting drug-production costs without increasing product liability
R
ecently, a pharmaceutical manufacturer based in London was fi ned £51,000 and ordered to pay costs of £104,898 by
a Crown Court, after it was convicted of supplying a medicinal product that was not of the nature or quality specifi ed in a prescription. The medicine made by the company contained just 12% of the strength specifi ed in the prescription, which made it ineff ective. Manufacturing defects are the most common cause of product liability claims. They involve injuries caused by pharmaceutical drugs that have been improperly manufactured or have somehow become tainted. This can be due to an error at the manufacturing facility or the pharmacy where the drug was made or bottled, or a problem that occurs during shipping or in labelling – in eff ect it could happen anywhere between the manufacturing plant and the place the consumer receives the drug. Whilst the manufacturer has little
control over its product once the batch leaves its facility, it does have control up until that point. But, to do this, the manufacturer must fi rst have clear overview of the whole production process. Advances in technology have resulted in many IT systems and solutions to support manufacturing processes. Manufacturers can now better manage execution of production procedures and recipes to get high-quality products. They can also generate process insights and make improvements to more easily meet
36 October 2022 | Automation
quality/regulatory requirements. The potential impact of manufacturing data exploitation is substantial, but strangely hasn’t led to many pharma companies generating actual and tangible benefi ts. This is mostly down to much of the data being siloed in production systems and machines that are not connected to manufacturing IT systems. Data is then hard to collect, combine and manage, and the risks to its integrity are also larger. Moreover, this makes any kind of
reporting and analytics signifi cantly more complicated. According to market research company Vanson Bourne, the average worker is spending eight hours per week acquiring, entering and moving data because of disconnected sources, and only seven hours per week making decisions on data. Now, more life-science companies are actively working on breaking down the data-isolating silos in their manufacturing, and not just to solve data integrity and regulatory compliance issues; they want to be able to identify critical production machines and product parameters, events and patterns, and actively manage them to avoid deviations and reduce costs. However, they can only do this if they are: 1. Collecting and storing production data;
2. Contextualising data; 3. Combining the process data with events to build tailored reports.
Moreover, the validity of the data and the process must be easily proven in a
potential audit. This can be hard to do when done manually or with generic reporting tools. A tool designed specifi cally for pharmaceutical manufacturing will help here.
Production reports and analytics MePIS PDM is an advanced process data management platform that enables the gathering, organising and managing of production data. It is the cornerstone for the creation of production reports, comprehensive production analyses and data integrity in pharmaceutical manufacturing. Tailored production reports can easily be
created, allowing an embedded audit trail, contributing to higher levels of GMP and regulatory compliance. It provides a basis for production transparency and process analytics. MePIS PDM ensures a real-time overview of equipment status and quicker reaction times in production. For deeper insights, time-series data and batches can be compared with actual events. MePIS PDM seamlessly connects to
production systems and machines, as well as production IT systems. Measured variables can be continuously monitored for quick identifi cation of abnormal batches and to determine the cause of any deviation. Production reports can be generated automatically and easily shared.
CONTACT:
iioTek;
www.iiotek.com Metronik;
www.metronik.net
automationmagazine.co.uk
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